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Quality Assurance Specialist I

Specialty:

Scientific

Title:

Quality Assurance Specialist I

City:

Memphis

State:

TN

Zip Code:

38141

Start date:

10-27-2017

Status:

Closed

Assignment Type:

Direct Hire

Job Id:

43795

Description

Quality Assurance Specialist I

Location: Memphis, TN

Shift: 1st shift, Monday - Friday

POSITION SUMMARY:

Under some supervision and with a good understanding of science and technology, monitors operations and participates in quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s North American operations.

ESSENTIAL FUNCTIONS:

Support the organization in monitoring of the compliance of laboratory testing, manufacturing, and clinical research and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GCP, GLP, GDP, and QSR requirements.

Work to accomplish efficient and effective quality review/audit of: certificates, procedures, protocols, risk assessments, reports, IQ/OQ/PQ documents, validations, deviations, complaints, and non-conformances/CAPAs, or other quality records, and provide professional and objective feedback based on the results.

Communicate effectively with internal personnel, as well as external customers and suppliers.

Collaborate effectively and positively within department and all other company departments.

Represent department and the organization favorably and in accordance with established Company standards.

Follow all company safety policies & other safety precautions within work area

Regular attendance and timeliness is essential

Additional daily duties as required:

Non-conformance and CAPA: Participate in the tracking, trouble shooting, investigation and progression of corrective and preventive actions related to non-conforming product or deviations from approved processes.

Complaints: Participate in the logging and investigation of customer complaints and feedback to the sales team.

Experienced in working to CAP/CLIA/GCP/GLP and Quality Management principles

Strong attention to detail and Quality commitment

High standards of mathematics and writing ability

Conscientious, thrives in high pressure work, and demonstrates strong initiative

PHYSICAL DEMANDS:

The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel. Job requires employee to walk considerable distances in the facility during the course of his or her work.